US – Bayer’s first-in-class nonsteroidal drug Kerendia is now available in the US for use following an approval as a therapy that can slow chronic kidney disease progression in patients with type 2 diabetes.
The approval is based on data from the Phase III FIDELIO-DKD renal outcomes study, which showed Kerendia significantly reduced the combined primary endpoint of chronic kidney disease progression, kidney failure or kidney death versus placebo when added to standard of care.
Kerendia also lowered the risk of a composite of time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospitalization, thereby by also meeting secondary targets.
The effectiveness of Kerendia in preventing kidney and heart complications was studied in the randomized, multicenter, double-blind, placebo-controlled phase 3 FIDELIO-DKD trial.
A total of 5674 adult patients with Chronic Kidney Disease (CKD) associated with type 2 diabetes were included in the study. Patients were randomly assigned to receive either Kerendia or a placebo.
Investigators compared the 2 groups for the number of patients whose disease progressed to a combined end point: those with at least 40% reduction in kidney function, progression to kidney failure, or kidney death.
The results of this study showed that 504 of the 2833 patients in the study experienced 1 of the events in the combined end point. This was compared with the 600 of the 2841 patients who received a placebo.
Investigators looked at the 2 groups further to examine the number of patients who experienced cardiovascular death, a non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure.
The results showed that 367 of the 2833 patients receiving Kerendia had at least 1 of the events in the combined end point compared with 420 of the 2841 patients who received a placebo.
CKD is common and can be found in up to 23% of patients with diabetes and according to data from CDC the disease is common in USA with 11% of the population affected in the country.
Diabetes is often associated with CKD, and for 45% of patients who receive dialysis therapy, diabetes is the primary cause of their kidney failure. Additionally, moderate to severe CKD is estimated to be found in 15-23% of patients with diabetes.
Patients with CKD and diabetes can experience complications related to fluid, electrolytes, and bodily waste buildup in the body as a result of faulty filtering. Further, this disease can sometimes progress to kidney failure and cause an elevated risk of heart disease.
Current treatment for diabetic kidney disease includes controlling blood pressure and blood sugar levels, reducing dietary protein intake, avoiding medications that may damage the kidneys, treating urinary tract infections and exercise and weight loss (under the supervision of a physician).